Consulting

When your business requires an expert independent opinion we are ready to assist.

Consulting is our commitment of support. Our statistical expertise spans all stages of development, from research, to validation, and to manufacture. Contact us for a free initial consultation on any statistical, manufacturing, or compliance issue.

Areas of Expertise:

Statistics for non-Statisticians

Statistical implications of the CGMP’s

Statistical Thinking

Process Capability Studies

  • Cp, Cpk
  • Tolerance Intervals for natural limits
  • Control charts in a GMP environment
  • Statistical Process Control / Statistical Quality Control

Process Analytical Technology, PAT

  • Three phases of PAT
  • True Process Knowledge

Design of Experiments, DoE

  • DoE for PAT
  • Validation by Design®
  • “Quality by Design”
  • “Design Space”
  • Ruggedness and robustness
  • Factorials, fractional factorials
  • Plackett-Burman designs
  • Response Surface Methodology, RSM

Data Analysis

  • Statistical graphics
  • Regression and correlation
  • Outliers and aberrant values; SOPs
  • Significant digits and rounding rules

Bergum’s Method for Content Uniformity

Out-of-Specification Results: FDA OOS Guidance

Trending and Out-of-Trend analysis, OOT

Sampling Plans

  • Square Root of (N)+1 plans
  • Reviewing sampling SOPs
  • ANSI/ASQ Z1.4 attribute plans
  • ANSI/ASQ Z1.9 variable plans
  • AQL = 0.00 for critical characteristics ?

ICH Q2: Analytical method validation

ICH Q6, Setting specifications; writing SOPs

  • X bar ± 3S, friend or foe?
  • Distribution analysis of historical data
  • Statistical Tolerance Intervals

ICH Q8 Pharmaceutical Development

  • DoE for product and process development

ICH Q9 Quality Risk Assessment

Quality Philosophy, TQM, Six Sigma

  • Deming, Juran, Ishikawa, Taguchi

USP <1010> Analytical Data

ASTM E11 Statistics and ASTM E55 PAT

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News & Events

Upcoming Course:
Thursday & Friday– September 28-29, 2017

DoE Basics for Validation by Design for PDA in Berlin, Germany
Learn More

Classes for 2018 being finalized now!


 

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